Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

NCT01180699 | Completed

• 1 other identifier: KUOA-02
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

Conditions

Influenza Vaccine

Keywords

adult solid organ transplant patients

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen

  4 weeks

Secondary Outcomes (1)

• Local and systemic adverse events to vaccination

  24 hours, 48 hours and 7 days after each vaccination

Study Arms (2)

influenza vaccine - intradermal

EXPERIMENTAL

intradermal versus intramuscular

Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza

influenza vaccine - intramuscular

ACTIVE COMPARATOR

Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza

Interventions

Influenza vaccine: Vaxigrip or Fluviral and Intanza BIOLOGICAL

Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.

influenza vaccine - intradermal; influenza vaccine - intramuscular

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 and ≤ 59,
• Greater than 3 months post-transplant,
• Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

You may not qualify if:

• Has already received influenza vaccination for 2010-2011 season;
• Egg allergy,
• Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
• Ongoing therapy for rejection,
• Febrile illness in the past two weeks,
• Unable to provide informed consent,
• Unable to comply with study protocol

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Deepali Kumar

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: August 12, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)